Cuidado em saúde ao adolescente em vulnerabilidade ao uso de drogas / Health care for adolescents who are susceptible to drug use

RESUMO Este artigo trata das adolescências, no plural, como construção histórico-social de um processo dinâmico, e do adolescente perante seus modos de vida e expressão em um contexto histórico-social e singular. Entende-se aqui que ações meramente prescritivas são insuficientes para responder às complexidades dos processos de adoecimento mental na sociedade contemporânea. Objetivou-se compreender o contexto das práticas de cuidado em saúde ao adolescente em vulnerabilidade, diante do uso de drogas, na dimensão das tensões dos campos de práticas do cuidado em saúde. Estudo descritivo exploratório de abordagem qualitativa, que realizou entrevistas com profissionais da área da saúde (Unidade Básica de Saúde e Centro de Atenção Psicossocial Infantojuvenil). Destacam-se as tensões no campo de práticas entre o modelo assistencial biomédico e de guerra às drogas versus o psicossocial/comunitário; redução de estigma; acesso; redução de danos e nos atendimentos individuais, bem como a importância de refletir e fomentar o processo de mudança da mentalidade diante do adoecimento mental, visando atualizar as formas de cuidar. Esse processo tem sido realizado conforme os princípios da Reforma Psiquiátrica Brasileira, com avanços e retrocessos que repercutem na atualização das práticas de cuidado em saúde mais alinhadas às propostas de ações psicossociais e redutoras de vulnerabilidade.

ABSTRACT This article deals with adolescences, in the plural, as a socio-historical construction of a dynamic process and with the experience of adolescents with their lifestyle and self-expression in a unique socio-historical context. It assumes that purely prescriptive measures are insufficient to address the complexity of mental illness processes in contemporary society. This study aims to understand the context of health care practices for vulnerable youth, particularly those involved in substance use, through the lens of tensions in health practice domains. This is an exploratory, descriptive study using a qualitative approach, with interviews conducted with health professionals (in Basic Health Unit and Psychosocial Care Center for Children and Adolescents). The study highlights the tensions within health practice between the biomedical model and the war on drugs and a community-based psychosocial approach; it underlines the need for reducing stigmatization, improving access, harm reduction, and individualized care. It also emphasizes the importance of considering and promoting a shift in mentality towards mental illness in order to develop care strategies. This process was carried out in line with the principles of the Brazilian Mental Health Reform, with advances and setbacks that affect the updating of health practices, which are more oriented towards proposals for psychosocial and vulnerability-reducing actions.

Research progress in therapy drug monitoring of levetiracetam / 中国药房

Levetiracetam （LEV） is the second generation of broad-spectrum anti-epileptic drug. LEV has the advantages of rapid absorption， short half-life， precise efficacy， good tolerance and few drug interactions. In order to improve the clinical efficacy of LEV， and reduce the occurrence of adverse reactions， children， pregnant women， the elderly， and patients with renal insufficiency should receive therapeutic drug monitoring （TDM）. Clinically， the samples are usually plasma or serum， and the TDM methods are mostly immunoassay or chromatography. There is currently no consensus on the effective concentration range of LEV， and the correlation between plasma concentration and adverse reactions is also unclear. The main factors affecting LEV plasma concentration include age， pregnancy， and patient compliance. How to interpret TDM results and adjust dosage based on the results will be the focus of future work.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine（Part 5）： Retrieval and Synthesis of Key Information on Rational Drug Use / 中医杂志

Recommendations for Chinese patent medicine （CPM） based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study， we discussed in detail of the key information on the rational use of CPM in five aspects， which are dosage， drug discontinuation， drug-drug and drug-food interactions， safety and economy. Following the process of multi-source search， synthesis and prioritization， it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions， policy documents， literature， and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally， methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.

Consensus on whole-process pharmaceutical care for iodine contrast medium / 中国药房

OBJECTIVE To explore the whole-process pharmaceutical care model of iodine contrast medium and promote the rational clinical use of iodine contrast medium. METHODS Clinical Professional Committee on Rational Drug Use of China Medical Education Association and Expert Committee on Drug Evaluation and Clinical Research of Guangdong Pharmaceutical Association organized domestic experts to establish a working group on the Consensus on the whole-process pharmaceutical care for iodine contrast medium. The working group conducted literature searches， evidence-based analysis， and discussions on the development process， indications， contraindications， adverse drug reactions， drug interactions， drug use for special population， pharmaceutical care， and other key topics to summarize the content and process of the whole-process pharmaceutical care for iodine contrast medium. This consensus was ultimately formed. RESULTS The consensus on whole-process pharmaceutical care for iodine contrast medium included an evaluation of the patient， renal function， combined drug use， and hydration regimen before examination， the presence of contrast agent extravasation or suspected acute adverse reactions during examination， observation time points and follow-up after examination， and the presentation of specific work in each stage through pharmaceutical care flowchart. The medication monitoring record form was also formed to record the work situation. CONCLUSIONS The consensus has established a whole-process pharmaceutical care system for iodine contrast medium， providing scientific evidence for clinical physicians and nursing staff in the rational use of such special drugs， and also serving as a reference for pharmacists in providing related pharmaceutical care.

Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine（Part 1）： Development Status and Characteristics / 中医杂志

The irrational use of Chinese patent medicines （CPM） is becoming more and more prominent， which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines， and promote its development， this paper introduced the concept of CPM guidelines， summarized the characteristics of the two development modes， namely “taking CPM as the key” and “taking disease/syndrome as the key”， and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems， three suggestions have been put forward to optimize the quality of CPM guidelines， which were clarifying the target users and scope of CPM guidelines， establishing an open and transparent mechanism of the personnel involvement and process steps， and formulating implementable and operable recommendations for the use of CPM.

Hepatitis B induced fulminant liver failure: A call for prevention

Acute fulminant hepatic failure is a condition in which a healthy liver deteriorates rapidly following an insult, resulting in the impairment of its synthetic functions. This condition is rare and is associated with high fatality rates. We report the case of a 19-year-old male who was brought to the emergency room in an unconscious state with jaundice and persistent fever for 2–3 weeks after recently commencing intravenous use of morphine. He was found to be hepatitis B surface antigen reactive, and his laboratory tests indicated severe liver dysfunction with elevated levels of serum bilirubin, aspartate transaminase, alanine transaminase, gamma-glutamyl transferase, and International normalized ratio. The patient was diagnosed with fulminant liver failure with coagulopathy and hepatic encephalopathy. The patient’s family was addressed and counseled regarding the urgent need for liver transplantation. However, due to a lack of funds and insurance, supportive treatment was the only option left. Despite all supportive measures, the patient expired within 48 h. This case highlights the importance of various socioeconomic issues involved with liver transplantation, as in a resource-limited setting, urgent transplantation seems nearly impossible. In addition, this case report raises certain ethical issues that need consideration, particularly in an injection drug use scenario. It also highlights the importance of addressing the rising issue of injection drug use among youth, particularly in the regions of Punjab.

AngioVac System for Infective Endocarditis: A New Treatment for an Old Disease

Three different patients presented to our institution with right-sided infective endocarditis (IE). All three were found to have vegetation on the tricuspid valve. These patients were started on appropriate antimicrobial therapy according to their blood cultures sensitivities. Despite this management, the patients� clinical status did not improve solely on antimicrobials. Surgery was, therefore, indicated to remove the vegetations. Traditionally, the appropriate management would have been invasive surgery. However, these patients were subjected to a novel treatment in our institution for right?sided IE: percutaneous mechanical vegetation debulking with an AngioVac system. After this procedure, all three patients� clinical status improved drastically. This new less invasive approach seems to offer the same results as the traditional invasive surgery, with faster recovery time. More comparative studies are needed to confirm this idea.

Naltrexona em baixa dose (LDN): tendência de consumo nas capitais brasileiras e Distrito Federal, 2014-2020 / Low-dose naltrexone (LDN): consumption trend in Brazilian capitals and the Federal District, 2014-2020

Resumo Estudo ecológico com objetivo de determinar o consumo de naltrexona em baixa dose (LDN) nas 26 capitais brasileiras e Distrito Federal e acompanhar a tendência entre os anos de 2014 e 2020. A coleta de dados da dispensação de naltrexona manipulada, se deu por meio do Sistema Nacional de Gerenciamento de Produtos Controlados, publicizado em 2020, considerando-se baixa dose prescrições de até 5 mg. O cálculo dos coeficientes de dispensação utilizou as estimativas populacionais do Instituto Brasileiro de Pesquisa Geografia e Estatística. Utilizou-se análise estatística descritiva e de regressão generalizada de Prais-Winsten para a série temporal. As tendências observadas foram classificadas em crescentes, estáveis ou decrescentes, com intervalo de confiança de 95% e nível de significância de 5%. Os resultados demonstraram maiores coeficientes de consumo de LDN nas regiões Centro-Oeste, Sul e Sudeste e menores nas Norte e Nordeste. Observou-se dispensação de LDN crescente em 55,6% das capitais, estacionária em 44,4% e ausência de coeficientes decrescentes. Apesar das evidências limitadas quanto à farmacoterapia de LDN e da sua prescrição off-label, os dados demonstram que a prescrição, dispensação e consumo vem crescendo no Brasil, com ênfase nas regiões centro-sul do país.

Abstract The scope of this paper is an ecological study to determine the consumption of low-dose naltrexone (LDN) in the 26 Brazilian capitals and the Federal District and monitor the trend between the years 2014 to 2020. Data collection on the dispensation of manipulated naltrexone was done through the National Management System of Controlled Products, published in 2020, considering low-dose prescriptions of up to 5 mg. The calculation of the dispensation coefficients used the population estimates of the Brazilian Institute of Geography and Statistics. Descriptive statistical analysis and generalized Prais-Winsten regression analysis were used for the time series analysis. The trends observed were classified as increasing, stable, or decreasing, with a 95% confidence interval and 5% significance level. The results showed higher LDN consumption coefficients in the Mid-West, South and Southeast regions and lower coefficients in the North and Northeast. Increasing dispensation of LDN was observed in 55.6% of the capitals, being stationary in 44.4%, with no decreasing coefficients. Despite the limited evidence regarding LDN pharmacotherapy and its off-label prescription, the data show that prescription, dispensing, and consumption have been on the increase in Brazil, with emphasis on the central-south regions of the country.

Cost-minimization analysis of drugs used for empirical treatment of urinary tract infection in a tertiary care hospital

Background: Urinary tract infections (UTIs) are one of the commonly encountered infections and a large number of drugs are indicated in UTI ranging from oral conventional drugs to most advanced injectable drugs. Cost-minimization analysis (CMA) is employed to project the least costly drug when two treatments are shown to be therapeutic equivalents. Aims and Objectives: This study aims to perform a CMA at a tertiary care center to determine the least expensive drug for UTI and to project a cheapest alternative from available options based on the results of CMA. Materials and Methods: This was a cross-sectional study conducted over duration of 3 months in the clinical departments on patients diagnosed to have UTI and prescribed empirical antimicrobial treatment. The approval of Institutional Ethics Committee was sought before beginning the study. Pattern of drug prescription and average cost incurred in the treatment of patients with empirical antimicrobial therapy was calculated. CMA included the projection of the least expensive drug based on average cost incurred per patient in outpatients and inpatients respectively. Results: A total of 59 patients of UTI given empirical treatment were included in the study. Fluoroquinolones and cephalosporins were commonly used drugs for empirical treatment of UTI. Nitrofurantoin (average cost of 11–14 Rs. per patient) can be projected as the cheapest drug for empirical treatment of UTI on outpatient basis as well as a drug to supplement injectables in indoor patients. Injectable ciprofloxacin can be projected as the most inexpensive alternative for empirical treatment of UTI in patients of the inpatient department. Conclusion: Nitrofurantoin for oral treatment and ciprofloxacin in injectable form are cheapest among available alternatives for empirical treatment of UTI. To prevent treatment failures and increase in cost of treatment, correlation of results of CMA with local antimicrobial sensitivity pattern is important.

Prevalence and predictors of depression among college going youth of Meghalaya: A cross-sectional study

Backgrounds: College years are characterized by transitioning from pre-adult to adulthood, a period of turmoil, adjusting to the new condition, separation from parental supervision, independence, and countering new things throughout everyday life. Depression and health-risk behaviors, including alcohol, tobacco, and illicit drug, are often found in college students, particularly during their first year. Aim: To study the prevalence and predictors of depression among college-going youth of Meghalaya, India. Materials and Methods: A cross-sectional community-based study has been undertaken to find the prevalence of depression, alcohol use, and drug use in college-going youth in Shillong, Meghalaya. A random sampling technique was used for the selection of colleges, and total enumeration was used for the selection of college-going students. A total of 358 respondents were selected for the present study. Permission from the college authority was obtained, and written informed consent was taken from the students. The participants have been explained the purpose of the study and the samples were selected voluntarily. The present study’s data were analyzed and interpreted using Statistical Package for Social Sciences version 20.0. Socio-demographic datasheet, Beck Depression Inventory-II, Hamilton Anxiety Rating Scale, Alcohol Use Disorder Identification Test, and drug abuse screening test were administered. Results: In the present study, 40.5% fall under the normal range of depression, while 38.3% had mild mood disturbance, 10.3% had borderline clinical depression, 9.7% had moderate depression, and severe depression was found in 1.1%. Alcohol use, drug use, and gender contribute significantly to the prediction of depression among college-going students ( F[5,19.551] = 855.3, P = 0.000) accounting for 21.7% variance. Conclusion: Our findings highlight the need for a college mental health program for early identification and screening of substance use and depression in college students.

Exploration and practice of rational drug use control mechanism based on performance appraisal / 中国药房

OBJECTIVE To further improve the rational drug use control mechanism based on performance appraisal， explore new paths of pharmaceutical care and promote the rational clinical drug use management to deepen development. METHODS The reform of pharmaceutical management system in our hospital was performed through implementing the “ten-point system of prescription behavior management”， supplemented by the two carriages of “strengthening prescription review” and “standardizing clinical medication”. By implementing a number of auxiliary measures such as man-machine integration pre-prescription review， improving pharmacists’ prescription review ability， optimizing prescription review mechanism in real time， regulating physicians’ off-label drug use behavior， and improving drug evaluation mechanism， pre-control and in-process intervention were completed. The evaluation results were incorporated into performance assessment by referring to the “ten-point system of prescription behavior management”， so as to realize multi-dimensional and fully closed-loop rational drug use management. The effects of management were evaluated by comparing the statistical results of related indexes before and after the management. RESULTS Compared with before management， irrational rate of prescriptions and medical orders in our hospital in 2022 decreased significantly， compared to the same period in 2020； the irrational rate of inpatient medical orders decreased from 5.00% in 2020 to 2.69% in 2022， and that of outpatient prescriptions decreased from 4.59% to 2.48%； the frequency of communication between clinical pharmacists and physicians increased； the times of clinical consultations increased from 16 to 58， and doctors’ acceptance of intervention for irrational drug use had improved from 52％ to 87％ ； physicians had a deeper understanding and recognition of clinical pharmaceutical care， the awareness of clinical rational drug use had been significantly improved. CONCLUSIONS The rational drug use control mechanism guided by performance appraisal further standardizes the issuance of prescriptions and medical orders， and makes physician-pharmacist cooperation more prominent， so as to realize the closed-loop pharmaceutical management of “pre- review， in-process supervision and post-evaluation”， and promote rational drug use in clinical practice.

Expert consensus on comprehensive clinical evaluation of antidepressant drugs / 中国药房

At present， many antidepressant drug categories have been marketed in China， but still lack a scientific and standardized system for drug comprehensive clinical evaluation. To guide and promote medical institutions to standardize the comprehensive clinical evaluation of antidepressant drugs， 19 clinical， pharmacy and evidence-based medicine experts from China were organized by the China Population Welfare Foundation to evaluate 11 drugs in 5 categories， including sertraline/escitalopram/ paroxetine/fluvoxamine/citalopram/fluoxetine/venlafaxine/duloxetine/vortioxetine/agomelatine/mirtazapine， through seminars and interviews， concerning clinical real-world data and evidence-based medicine， and to form the first draft of Expert Consensus on Comprehensive Clinical Evaluation of Antidepressant drugs， which is finalized after peer review by 18 clinical and pharmacy experts. The evaluation system of this expert consensus adopts the quantitative evaluation system of percentile and carries out a systematic evaluation from 6 dimensions of effectiveness， safety， economy， suitability， accessibility and innovativeness， while the evaluation dimensions are more detailed， with the operability of the drug evaluation system and the characteristics of drugs in the field of antidepressants. It aims to provide a theoretical basis for the rational use of drugs in the field of psychiatric disorders in medical institutions and help improve the quality of pharmacy services to better meet the needs of the people for medication.

Establishment and application of DUE criteria of Dolasetron / 药学实践杂志

Objective To establish the drug use evaluation ( DUE) of Dolasetron, evaluate the rationality of the clinical use of Dolasetron and provide a reference for the rationally clinical use of Dolasetron．Methods On the basis of Dolasetron DUE criteria, a retrospective analysis was made in 794 hospitalized patients from January 2021 to June 2021. Results The drug use evaluation criterion on Dolasetron consisted of drug indications, drug use process, the result of drug use and indication management. Conclusion There are some inappropriate medication problems in Dolasetron utilization in the hospital. The DUE criterion is very practical which could be used to standardize the clinical utilization of Dolasetron.

Practice of pediatric pharmacists providing internet medication consultation services based on the platform of “Our Pharmacists” / 中国药房

OBJECTIVE To analyze the effect of pharmaceutical practice of pediatric pharmacists providing internet medication consultation services. METHODS A total of 8 356 children’s medication cases through the “Our Pharmacists” online medication consultation platform （hereinafter referred to as “Our Pharmacists”） were collected from July 2020 to June 2022. The general information， disease type and irrational drug use were analyzed statistically. RESULTS Among 8 356 cases， 4 234 were male and 4 122 were female； the age of children was mainly from 12 months to 3 years old； the consulting diseases were mainly respiratory diseases （46.56%）， followed by digestive system diseases （18.41%） and skin system diseases （12.71%）. Among respiratory diseases， the proportion of irrational drug use was 92.30%， mainly including the use of antibiotics without indication （83.59%）， inappropriate selection of Chinese patent medicines （61.14%） and compound cold medicines （49.77%）， etc. Among digestive system diseases， the proportion of irrational drug use was 71.15%， mainly including not using oral rehydration salts （48.85%）， inappropriate use of probiotics （31.19%）， the use of antibiotics without indication （26.89%）， etc. A total of 4 273 evaluations of pharmacist services were received from child guardians， with a five-star rating of 99.88%. CONCLUSIONS Pharmacists provide pediatric medication consultation services through “Our Pharmacists”， providing individualized evidence-based medication suggestions， increasing the safety of drug use and satisfaction with pharmaceutical care， and ensuring the safety of children medication.

Mining and analysis of adverse drug event signals related to mepolizumab / 中国药房

OBJECTIVE To provide reference for rational clinical use of mepolizumab. METHODS The reporting odds ratio method and Bayesian confidence propagation neural network method were used to conduct signal mining and analysis of adverse drug event （ADE） reports related to mepolizumab in the United States Food and Drug Administration Adverse Event Reporting System from the first quarter of 2016 to the third quarter of 2022. RESULTS A total of 57 501 ADE reports were extracted with mepolizumab as the primary suspect drug， involving 16 358 patients. Among these reports， the proportion of males （23.51%） was lower than females （50.48%）. The reporting countries were primarily the United States （51.91%） and Canada （29.94%）. Consumers （71.18%） constituted the main reporting population. A total of 172 ADE-positive signals were identified， mainly involving 13 system organ classes such as the respiratory， thoracic and mediastinal disorders （41.63%）， as well as infectious and parasitic diseases （14.16%）. There were 60 high-risk signals， including 15 that were explicitly mentioned or related to adverse reactions in the drug instructions of mepolizumab and 45 signals （such as asthmatic crisis， sputum discoloured， purulent sputum， sleep disorder due to a general medical condition） were newly identified high-risk signals. Among them， 11 high-risk signals exhibited gender or age differences. CONCLUSIONS When clinically using mepolizumab， in addition to the adverse reactions mentioned in the drug instruction， special attention should also be given to changes in the nature of sputum， painful respiration， and sleep disorders.

Effect of posaconazole combined with proton pump inhibitors on blood concentrations and invasive fungal infec-tion in patients with malignant hematological disorders / 中国药房

OBJECTIVE To explore the effects of posaconazole combined with proton pump inhibitors （PPI） on the blood concentration and the risk of invasive fungal disease （IFD） in patients with malignant hematological disorder. METHODS In accordance with the random number table method， 40 patients with malignant hematological disorders who were admitted to the hematology department of our hospital between December 2020 and December 2021 were chosen and divided into control group （20 cases） and observation group （20 cases）. The control group received Posaconazole oral suspension alone， while the observation group received Posaconazole oral suspension combined with PPI. The incidence of IFD， attainment rate of blood concentration， the time from the start of prophylaxis to IFD onset， the fatality associated with IFD， treatment of infected patients， and blood concentrations of posaconazole on 7th， 14th， 21st， and 28th day after posaconazole application were compared between 2 groups； the occurrence of adverse events during drug administration in the two groups was recorded. RESULTS The study was stopped because 2 patients in the observation group and 9 patients in the control group received hospital departures after taking posaconazole for fewer than 7 days. The incidence of IFD in the observation group was significantly higher than control group， and the attainment rate of blood concentration in the observation group was significantly lower than control group （P＜0.05）. There was no significant difference in the time from the start of prophylaxis to IFD onset， the fatality associated with IFD， treatment of infected patients and the incidence of adverse events （P＞ 0.05）. The blood concentration of posaconazole in the observation group was significantly lower than control group on 7th day of medication （P＜0.05）； there was no significant in blood concentration of posaconazole between 2 groups on the 14th day of medication （P＞0.05）. CONCLUSIONS Posaconazole combined with PPI can reduce the blood concentration of patients with malignant hematological disorders， increase the risk of IFD. Clinical practice should try to avoid the combination of the two or use them under the guidance of therapeutic drug monitoring.

Analysis of ADR reports caused by cefotaxime sodium in Shandong province and effects of skin test on serious ADR / 中国药房

OBJECTIVE To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） caused by cefotaxime sodium in Shandong province， and to explore the effects of skin test before medication of cefotaxime sodium on serious ADR， so as to provide reference for safe drug use in clinic. METHODS The relevant data of cefotaxime sodium-induced ADR reported by Shandong Province ADR Monitoring Center during December 2019 to December 2021 were collected from National ADR Monitoring System. The ADR classification， age， gender， ADR occurrence time， route of administration， history of allergy， primary diseases， ADR systems/organs involved， clinical manifestations， outcome， skin test or not before medication were statistically analyzed. RESULTS A total of 1 057 ADR reports caused by cefotaxime sodium were included. Among them， there were 867 patients （82.02%） with general ADR and 190 patients （17.98%） with serious ADR. The majority were ＜11 years old （40.30%）. The main route of administration was intravenous drip （96.69%）. A total of 1 033 patients （97.73%） developed ADR 30 min to 24 h after medication. A total of 814 patients （77.01%） had no history of allergy. The primary diseases were respiratory system infection （56.58%）. Main systems/organs involved in ADR were skin and its appendants， digestive system and respiratory system， and its clinical manifestations were rash， pruritus， nausea， vomiting， chest tightness， etc. After withdrawal or symptomatic treatment， 1 050 patients （99.34%） were cured or improved. Before the use of cefotaxime sodium， 850 patients underwent skin test （151 patients occurred serious ADR）； there was no statistical significance in the incidence of serious renzhen202102@163.com ADR， compared with the incidence of serious ADR in 207 patients without skin test （39 patients occurred serious ADR）（P＝0.718）. CONCLUSIONS ADR caused by cefotaxime sodium is mainly seen in patients ＜11 years old， mostly occurring 30 min to 24 h after intravenous drip； skin test before medication of cefotaxime sodium cannot reduce the risk of serious ADR. Before using cefotaxime sodium in clinical practice， patients should be asked about their allergy and medication history in detail. During use， it is important to focus on the patient’s condition within 24 h after medication to prevent serious ADR and ensure the safety of clinical medication.

Application practice of drug clinical comprehensive evaluation thinking in management of temporary drug purchase in hospital / 中国药房

OBJECTIVE To explore the construction of a new scientific management model for temporary drug purchase，and to provide a reference for hospitals to improve the level of rational drug use. METHODS Guided by clinical diagnosis and treatment needs and patient medication safety， our hospital carried out the whole process management practice of temporarily purchased drugs by optimizing the review process， creating a review team， formulating pre-audit and post follow-up evaluation standards based on comprehensive drug evaluation， and evaluated the practice effect through the number of temporary purchase applications， implementation rate， drug structure optimization and other indicators. RESULTS Since January 2021， our hospital had implemented a new mode of temporary drug purchase management. By December 2022， clinical pharmacists had reviewed 111 temporary drug procurement applications， effectively intercepted 13 irrational drug use applications （11.71%）， reduced the overall implementation rate of temporary drug procurement by 8.36%，and proposed five batches of drug structure optimization suggestions； 24 drugs were successively introduced such as camrelizumab，sorafenib，busulfan. After optimizing the management mode，the number of temporary drug procurement applications decreased by more than half from 133 in 2019 and 138 in 2020 to 66 in 2021 and 45 in 2022. CONCLUSIONS The model is helpful to optimize the hospital drug catalog， strengthen rational drug use，ensure the safety of patients’ drug use， and fully reflects the professional value of clinical pharmacists in hospital pharmacy management and rational drug use.

Enlightenment of Japan expanded access clinical trial system to China’s compassionate drug use system / 中国药房

The system of compassionate drug use in China is in the preliminary exploration stage， and the formal management methods and specific implementation rules have not been promulgated， which needs to be further optimized and perfected. Japan realizes the advanced use of unapproved drugs by expanded access clinical trial system， and makes clear provisions on information acquisition， target patient， informed consent， subject of application， implementation plan， handling of refusal to administer medication， drug expenses， implementation deadline， compensation for accidental damages， post-approval data review after expanded access clinical trials. When the enterprise refuses to give drugs because of the “legitimacy reasons of the system”， the attending physician can also apply to the Ministry of Health， Labor and Welfare， and the Ministry of Health， Labor and Welfare will conduct the licensing evaluation to maximize the drug for patients. This “refusal to administer” reprocessing is a unique regulation in Japan， which ensures the accessibility of drugs to the greatest extent possible. Based on the analysis of the expanded access clinical trial system in Japan， it is found that our country could further build the information platform for compassionate drug use， play the leading role of physicians， protect the interests of enterprises， pay attention to the ethical review， and make drug cost payment problems further clear in order to improve and optimize the system of compassionate drug use.

Research hotspots and trends on potentially inappropriate medication from 2012 to 2021 / 中国药房

OBJECTIVE To quantitatively and qualitatively analyze the progress of potentially inappropriate medication （PIM） research by means of bibliometrics， and to predict the hotspots and trends of PIM， so as to provide reference for PIM research in China. METHODS The research literature related to PIM were searched from Web of Science core database， and the publication trend of the literature was analyzed on the bibliometric online analysis platform and CiteSpace 5.8.R3 software. The research results were visualized and analyzed， and the research hotspots of PIM were summarized through gCLUTO. RESULTS About PIM research， the annual number of the literature issued from 2012 to 2021 showed a continuous growth trend totally； the United States had the largest number of literature （241 pieces）； the University of Sydney in Australia was the research institution with the largest number of literature （59 pieces）； O’Mahony D from University College Cork， Ireland， published the most literature （23 pieces）； the research of PIM involved 57 disciplines， among which there was the largest number of literature about gerontology （384 pieces）； International Journal of Clinical Pharmacy was the journal with the largest number of literature （61 pieces）； Journal of the American Geriatrics Society was cited most frequently （1 197 times）. The hotspots of PIM research mainly focused on seven aspects： the standard of PIM， the safety and economy research of PIM， the risk factors research of PIM， the PIM research of chronic patients， the PIM research of antipsychotics， the research of pharmacists’ participation in PIM management， and the PIM research about palliative care of tumor patients. CONCLUSIONS The heat of research on PIM has been on the rise， and there is little cooperation between countries and institutions， and more cooperation is needed. In the future， the focus of Chinese pharmacists’ research on PIM may be on the deep localization of PIM standards， PIM intervention and precise medication guidance， and PIM management of specific diseases and drugs.